Heart of the Matter

On a recent visit to the campus of my alma mater, I had a chance to visit some of the biomedical research laboratories. One of those is under the direction of a tenured professor who is making new biodegradable blood vessels the size of a coronary artery that will last long enough to allow for new fibrous tissue to form and replace the degrading substance. Even more exciting is the fact that the new vessel does not initiate an inflammatory reaction, since the vessel lumen will not be a site for platelet activation and in-situ thrombosis.

The professor was just as excited that a venture capitalist had just obtained the license to develop the technology and was about to begin human testing of the vessel in Asia.

Unfortunately, that is where a host of new devices and drugs are being tested.

Compared with the pharmaceutical industry trials, which have used a mixture of domestic and international sites for new drugs research, device trials have used international and particularly European sites for the development of new products. The development of new stents, for instance, was almost exclusive to Europe, and provided this therapy to Europeans far earlier than to Americans. This migration is a result of a more-receptive approval environment and the fact that human testing in Europe and Asia is recruitment for trials is faster and less expensive.

Since 1999, the number of new Premarket Approvals (PMAs) – the Food and Drug Administration’s regulatory process that is required before a novel device with significant patient health risks can get to market – has decrease significantly. In 2000, the FDA approved approximately 60 PMAs; by 2009, the number of approvals had decreased to 15. According to a device industry–supported survey of 176 of 750 potential medical technology companies (FDA Impact on U.S. Medical Technology Innovation, November 2010), the approval process for a PMA was 54 months in the United States and 11 months in Europe. The survey enumerates a number of process problems that confront the FDA, but the major issue noted by the companies surveyed was that the FDA has become much more risk averse and concerned about safety.

The rush to market, of course, is the driving force behind the increased concern of these delays. Venture capitalists that provide the resources for many small device companies see time as money. They are driven more by their desire to get their product to market quickly and they have a limited concern or appreciation for patient safety. Despite the spate of recent safety problems both in cardiology and orthopedics, they tend to minimize the importance of those problems. The safety aspects of many devices may not, of course, be knowable in the short term and not be measurable in the time frame of an 18- or 24-month clinical trial, but may lie in the distant future.

Much of this overseas migration of science is a result of the significantly lower infrastructure costs in Europe and – especially – in Asia. The per-patient costs in India, for instance, are a fraction of what they are in the United States, and the access to patients who can participate in trials is much more easily obtained. This is largely a result of closer physician involvement in the recruiting of patients, and the reluctance of both patients and doctors in the United States to participate in the clinical research trials. Patients hesitate because of a suspicious environment about clinical trials, and doctors are reluctant because they are too busy and are underpaid for their participation. The paradox of this process is that devices and drugs that are tested outside the United States may, because of their cost, be available only to U.S. patients. Whether clinical data obtained in foreign populations are applicable to the U.S. population is also uncertain.

A recent letter from 41 members of Congress, including 6 from Minnesota (which is the U.S. capital of new device companies), has placed increased pressure on the FDA to expedite the approval process and to bring the testing home to the United States ("Members of Minn. delegation urge FDA to speed medical device approvals," Minnesota Independent, Nov. 8, 2011). Of course the return of testing to our shores would be very advantageous to the approval process, but that same acceleration of the process could result in significant patient hazards. The balance between expeditious approval and safety has been an issue that has been going back and forth for the last 20 years, and will continue to be played out in the future.

On a recent visit to the campus of my alma mater, I had a chance to visit some of the biomedical research laboratories. One of those is under the direction of a tenured professor who is making new biodegradable blood vessels the size of a coronary artery that will last long enough to allow for new fibrous tissue to form and replace the degrading substance. Even more exciting is the fact that the new vessel does not initiate an inflammatory reaction, since the vessel lumen will not be a site for platelet activation and in-situ thrombosis.

The professor was just as excited that a venture capitalist had just obtained the license to develop the technology and was about to begin human testing of the vessel in Asia.

Unfortunately, that is where a host of new devices and drugs are being tested.

Compared with the pharmaceutical industry trials, which have used a mixture of domestic and international sites for new drugs research, device trials have used international and particularly European sites for the development of new products. The development of new stents, for instance, was almost exclusive to Europe, and provided this therapy to Europeans far earlier than to Americans. This migration is a result of a more-receptive approval environment and the fact that human testing in Europe and Asia is recruitment for trials is faster and less expensive.

Since 1999, the number of new Premarket Approvals (PMAs) – the Food and Drug Administration’s regulatory process that is required before a novel device with significant patient health risks can get to market – has decrease significantly. In 2000, the FDA approved approximately 60 PMAs; by 2009, the number of approvals had decreased to 15. According to a device industry–supported survey of 176 of 750 potential medical technology companies (FDA Impact on U.S. Medical Technology Innovation, November 2010), the approval process for a PMA was 54 months in the United States and 11 months in Europe. The survey enumerates a number of process problems that confront the FDA, but the major issue noted by the companies surveyed was that the FDA has become much more risk averse and concerned about safety.

The rush to market, of course, is the driving force behind the increased concern of these delays. Venture capitalists that provide the resources for many small device companies see time as money. They are driven more by their desire to get their product to market quickly and they have a limited concern or appreciation for patient safety. Despite the spate of recent safety problems both in cardiology and orthopedics, they tend to minimize the importance of those problems. The safety aspects of many devices may not, of course, be knowable in the short term and not be measurable in the time frame of an 18- or 24-month clinical trial, but may lie in the distant future.

Much of this overseas migration of science is a result of the significantly lower infrastructure costs in Europe and – especially – in Asia. The per-patient costs in India, for instance, are a fraction of what they are in the United States, and the access to patients who can participate in trials is much more easily obtained. This is largely a result of closer physician involvement in the recruiting of patients, and the reluctance of both patients and doctors in the United States to participate in the clinical research trials. Patients hesitate because of a suspicious environment about clinical trials, and doctors are reluctant because they are too busy and are underpaid for their participation. The paradox of this process is that devices and drugs that are tested outside the United States may, because of their cost, be available only to U.S. patients. Whether clinical data obtained in foreign populations are applicable to the U.S. population is also uncertain.

A recent letter from 41 members of Congress, including 6 from Minnesota (which is the U.S. capital of new device companies), has placed increased pressure on the FDA to expedite the approval process and to bring the testing home to the United States ("Members of Minn. delegation urge FDA to speed medical device approvals," Minnesota Independent, Nov. 8, 2011). Of course the return of testing to our shores would be very advantageous to the approval process, but that same acceleration of the process could result in significant patient hazards. The balance between expeditious approval and safety has been an issue that has been going back and forth for the last 20 years, and will continue to be played out in the future.

On a recent visit to the campus of my alma mater, I had a chance to visit some of the biomedical research laboratories. One of those is under the direction of a tenured professor who is making new biodegradable blood vessels the size of a coronary artery that will last long enough to allow for new fibrous tissue to form and replace the degrading substance. Even more exciting is the fact that the new vessel does not initiate an inflammatory reaction, since the vessel lumen will not be a site for platelet activation and in-situ thrombosis.

The professor was just as excited that a venture capitalist had just obtained the license to develop the technology and was about to begin human testing of the vessel in Asia.

Unfortunately, that is where a host of new devices and drugs are being tested.

Compared with the pharmaceutical industry trials, which have used a mixture of domestic and international sites for new drugs research, device trials have used international and particularly European sites for the development of new products. The development of new stents, for instance, was almost exclusive to Europe, and provided this therapy to Europeans far earlier than to Americans. This migration is a result of a more-receptive approval environment and the fact that human testing in Europe and Asia is recruitment for trials is faster and less expensive.

Since 1999, the number of new Premarket Approvals (PMAs) – the Food and Drug Administration’s regulatory process that is required before a novel device with significant patient health risks can get to market – has decrease significantly. In 2000, the FDA approved approximately 60 PMAs; by 2009, the number of approvals had decreased to 15. According to a device industry–supported survey of 176 of 750 potential medical technology companies (FDA Impact on U.S. Medical Technology Innovation, November 2010), the approval process for a PMA was 54 months in the United States and 11 months in Europe. The survey enumerates a number of process problems that confront the FDA, but the major issue noted by the companies surveyed was that the FDA has become much more risk averse and concerned about safety.

The rush to market, of course, is the driving force behind the increased concern of these delays. Venture capitalists that provide the resources for many small device companies see time as money. They are driven more by their desire to get their product to market quickly and they have a limited concern or appreciation for patient safety. Despite the spate of recent safety problems both in cardiology and orthopedics, they tend to minimize the importance of those problems. The safety aspects of many devices may not, of course, be knowable in the short term and not be measurable in the time frame of an 18- or 24-month clinical trial, but may lie in the distant future.

Much of this overseas migration of science is a result of the significantly lower infrastructure costs in Europe and – especially – in Asia. The per-patient costs in India, for instance, are a fraction of what they are in the United States, and the access to patients who can participate in trials is much more easily obtained. This is largely a result of closer physician involvement in the recruiting of patients, and the reluctance of both patients and doctors in the United States to participate in the clinical research trials. Patients hesitate because of a suspicious environment about clinical trials, and doctors are reluctant because they are too busy and are underpaid for their participation. The paradox of this process is that devices and drugs that are tested outside the United States may, because of their cost, be available only to U.S. patients. Whether clinical data obtained in foreign populations are applicable to the U.S. population is also uncertain.

A recent letter from 41 members of Congress, including 6 from Minnesota (which is the U.S. capital of new device companies), has placed increased pressure on the FDA to expedite the approval process and to bring the testing home to the United States ("Members of Minn. delegation urge FDA to speed medical device approvals," Minnesota Independent, Nov. 8, 2011). Of course the return of testing to our shores would be very advantageous to the approval process, but that same acceleration of the process could result in significant patient hazards. The balance between expeditious approval and safety has been an issue that has been going back and forth for the last 20 years, and will continue to be played out in the future.

The measurement of quality of care has been the mantra of health policy care for the past decade, and has become as American as apple pie and Chevrolet. Yet there have been few data showing that the institution of quality of care guidelines has had any impact on mortality or morbidity.

Despite this lack of data, hospitals are being financially rewarded or penalized based on their ability to meet guidelines established by the Center for Medicare and Medicaid Services in conjunction with the American College of Cardiology and the American Heart Association. Two recent reports provide insight on the progress we have achieved with guidelines in heart failure and in instituting the shortening of the door-to-balloon time (D2B) for percutaneous coronary artery intervention (PCI) in ST-segment elevation MI.

Decreasing heart failure readmission within 30 days, which occurs in approximately one-third of hospitalized patients, has become a target for the quality improvement process. Using the "Get With the Guidelines Heart Failure" registry, a recent analysis indicates that there is a very poor correlation between the achievement or those standards and the 30 day mortality and readmission rate (Circulation 2011;124:712-9).

The guidelines include measurement of cardiac function, application of the usual heart failure medications, and discharge instructions. Data were collected in almost 20,000 patients in 153 hospitals during 2005. Adherence to these guidelines was quite good and was achieved in more than 75% of the hospitals, yet it was unrelated to the 30 day mortality or hospital readmission.

The authors emphasized that the factors that affect survival and readmission are very heterogeneous. Basing pay-for-performance standards on a single measure (such as readmission rates) may penalize institutions that face impediments that are unrelated to performance measurements. Penalizing hospitals that have high readmission rates as a result of a large populations of vulnerable patients may penalize institutions that actually could benefit from more resources in order to achieve better outcomes.

The effectiveness of PCI, when it is performed in less than 90 minutes in STEMI patients, has been supported by clinical data from selected cardiac centers. The application to the larger patient population of the guideline to shorten D2B time to less than 90 minutes has been championed by the ACC, which launched the D2B Alliance in 2006 and by the AHA in 2007 with its Mission: Lifeline program.

The success of these efforts was reported in August (Circulation 2011;124:1038-45) and indicates that in a selected group of CMS-reporting hospitals, D2B time decreased from 96 minutes in 2005 to 64 minutes in 2010. In addition, the percentage of patients with a D2B time of less than 90 minutes increased from 44% to 91%, and that of patients with D2B of less than 75 minutes rose from 27% to 70%. The success of this effort is to be applauded, but the report is striking for its absence of any information regarding outcomes of the shortened D2B time. Unfortunately, there is little outcome information available, with the exception of data from Michigan on all Medicare providers in that state, which indicates that although D2B time decreased by 90 minutes, there was no significant benefit.

Measurement of quality remains elusive, in spite of the good intentions of physicians and health planners to use a variety of seemingly beneficial criteria for its definition.

As consumers, we know that quality is not easy to measure. Most of us can compare the quality of American automobiles vs. their foreign competitors by "kicking the tires," that is, by doing a little research. But even with this knowledge, we are not always sure that the particular car we buy will be better or last longer. Health care faces the same problem. Establishing quality care measurements will require a great deal of further research before we can reward or penalize hospitals and physicians for their performance.

It is possible that in our zeal to measure what we can, we are confusing process with content. How to put a number on the performance that leads to quality remains uncertain using our current methodology.-

Dr. Sidney Goldstein is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The measurement of quality of care has been the mantra of health policy care for the past decade, and has become as American as apple pie and Chevrolet. Yet there have been few data showing that the institution of quality of care guidelines has had any impact on mortality or morbidity.

Despite this lack of data, hospitals are being financially rewarded or penalized based on their ability to meet guidelines established by the Center for Medicare and Medicaid Services in conjunction with the American College of Cardiology and the American Heart Association. Two recent reports provide insight on the progress we have achieved with guidelines in heart failure and in instituting the shortening of the door-to-balloon time (D2B) for percutaneous coronary artery intervention (PCI) in ST-segment elevation MI.

Decreasing heart failure readmission within 30 days, which occurs in approximately one-third of hospitalized patients, has become a target for the quality improvement process. Using the "Get With the Guidelines Heart Failure" registry, a recent analysis indicates that there is a very poor correlation between the achievement or those standards and the 30 day mortality and readmission rate (Circulation 2011;124:712-9).

The guidelines include measurement of cardiac function, application of the usual heart failure medications, and discharge instructions. Data were collected in almost 20,000 patients in 153 hospitals during 2005. Adherence to these guidelines was quite good and was achieved in more than 75% of the hospitals, yet it was unrelated to the 30 day mortality or hospital readmission.

The authors emphasized that the factors that affect survival and readmission are very heterogeneous. Basing pay-for-performance standards on a single measure (such as readmission rates) may penalize institutions that face impediments that are unrelated to performance measurements. Penalizing hospitals that have high readmission rates as a result of a large populations of vulnerable patients may penalize institutions that actually could benefit from more resources in order to achieve better outcomes.

The effectiveness of PCI, when it is performed in less than 90 minutes in STEMI patients, has been supported by clinical data from selected cardiac centers. The application to the larger patient population of the guideline to shorten D2B time to less than 90 minutes has been championed by the ACC, which launched the D2B Alliance in 2006 and by the AHA in 2007 with its Mission: Lifeline program.

The success of these efforts was reported in August (Circulation 2011;124:1038-45) and indicates that in a selected group of CMS-reporting hospitals, D2B time decreased from 96 minutes in 2005 to 64 minutes in 2010. In addition, the percentage of patients with a D2B time of less than 90 minutes increased from 44% to 91%, and that of patients with D2B of less than 75 minutes rose from 27% to 70%. The success of this effort is to be applauded, but the report is striking for its absence of any information regarding outcomes of the shortened D2B time. Unfortunately, there is little outcome information available, with the exception of data from Michigan on all Medicare providers in that state, which indicates that although D2B time decreased by 90 minutes, there was no significant benefit.

Measurement of quality remains elusive, in spite of the good intentions of physicians and health planners to use a variety of seemingly beneficial criteria for its definition.

As consumers, we know that quality is not easy to measure. Most of us can compare the quality of American automobiles vs. their foreign competitors by "kicking the tires," that is, by doing a little research. But even with this knowledge, we are not always sure that the particular car we buy will be better or last longer. Health care faces the same problem. Establishing quality care measurements will require a great deal of further research before we can reward or penalize hospitals and physicians for their performance.

It is possible that in our zeal to measure what we can, we are confusing process with content. How to put a number on the performance that leads to quality remains uncertain using our current methodology.-

Dr. Sidney Goldstein is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The measurement of quality of care has been the mantra of health policy care for the past decade, and has become as American as apple pie and Chevrolet. Yet there have been few data showing that the institution of quality of care guidelines has had any impact on mortality or morbidity.

Despite this lack of data, hospitals are being financially rewarded or penalized based on their ability to meet guidelines established by the Center for Medicare and Medicaid Services in conjunction with the American College of Cardiology and the American Heart Association. Two recent reports provide insight on the progress we have achieved with guidelines in heart failure and in instituting the shortening of the door-to-balloon time (D2B) for percutaneous coronary artery intervention (PCI) in ST-segment elevation MI.

Decreasing heart failure readmission within 30 days, which occurs in approximately one-third of hospitalized patients, has become a target for the quality improvement process. Using the "Get With the Guidelines Heart Failure" registry, a recent analysis indicates that there is a very poor correlation between the achievement or those standards and the 30 day mortality and readmission rate (Circulation 2011;124:712-9).

The guidelines include measurement of cardiac function, application of the usual heart failure medications, and discharge instructions. Data were collected in almost 20,000 patients in 153 hospitals during 2005. Adherence to these guidelines was quite good and was achieved in more than 75% of the hospitals, yet it was unrelated to the 30 day mortality or hospital readmission.

The authors emphasized that the factors that affect survival and readmission are very heterogeneous. Basing pay-for-performance standards on a single measure (such as readmission rates) may penalize institutions that face impediments that are unrelated to performance measurements. Penalizing hospitals that have high readmission rates as a result of a large populations of vulnerable patients may penalize institutions that actually could benefit from more resources in order to achieve better outcomes.

The effectiveness of PCI, when it is performed in less than 90 minutes in STEMI patients, has been supported by clinical data from selected cardiac centers. The application to the larger patient population of the guideline to shorten D2B time to less than 90 minutes has been championed by the ACC, which launched the D2B Alliance in 2006 and by the AHA in 2007 with its Mission: Lifeline program.

The success of these efforts was reported in August (Circulation 2011;124:1038-45) and indicates that in a selected group of CMS-reporting hospitals, D2B time decreased from 96 minutes in 2005 to 64 minutes in 2010. In addition, the percentage of patients with a D2B time of less than 90 minutes increased from 44% to 91%, and that of patients with D2B of less than 75 minutes rose from 27% to 70%. The success of this effort is to be applauded, but the report is striking for its absence of any information regarding outcomes of the shortened D2B time. Unfortunately, there is little outcome information available, with the exception of data from Michigan on all Medicare providers in that state, which indicates that although D2B time decreased by 90 minutes, there was no significant benefit.

Measurement of quality remains elusive, in spite of the good intentions of physicians and health planners to use a variety of seemingly beneficial criteria for its definition.

As consumers, we know that quality is not easy to measure. Most of us can compare the quality of American automobiles vs. their foreign competitors by "kicking the tires," that is, by doing a little research. But even with this knowledge, we are not always sure that the particular car we buy will be better or last longer. Health care faces the same problem. Establishing quality care measurements will require a great deal of further research before we can reward or penalize hospitals and physicians for their performance.

It is possible that in our zeal to measure what we can, we are confusing process with content. How to put a number on the performance that leads to quality remains uncertain using our current methodology.-

Dr. Sidney Goldstein is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Over the past century, the management of American hospitals has changed dramatically. These changes have occurred as a result of major shifts in the social and financial environment and have had a major effect on how medicine was practiced in the past and how it will be practiced in the future.

The American hospital as we know it today was established in the late 19th and early 20th centuries largely by the Catholic, Protestant, and Jewish communities to provide care for the elderly and chronically ill patients who otherwise would not be cared for at home.

With the development of surgical techniques from tonsillectomies to cholecystectomies in the mid-20th century, they became the workshop of general surgeons, who largely controlled the hospitals. With the subsequent development of antibiotics and medical treatment for cardiovascular disease, the internal medicine specialties demanded a larger role in institutional management.

The increased complexity and expense of medical care led to concerns about how to provide a financial base for medical care and led to the establishment of private medical insurance programs, and ultimately, to Medicare and Medicaid. Hospitals were no longer concerned about being a health resource but suddenly became a profit center. Community hospitals expanded in order to meet the needs of new technologies with the support of grants and loans from the federal government.

With this growth, the management of the hospital of the 20th century required the creation of a new breed of hospital staff: the hospital administrator. They were hired to manage the financial and administrative aspects of these new and growing organizations. Although the hospital administration was structured to provide equipoise between the medical and financial priorities of the hospital, that balance was not easily maintained, and as the financial aspects became central, the hospital administrator became supreme and physicians lost control.

Today, the American hospital has become central to the support of nonprofit and for-profit regional and national health care conglomerates, and control has become the province of boards of directors with little medical input and larger community control. As a consequence, the physician has now become a real or quasi-employee of the hospital.

In a recent perspective paper, Dr. Richard Gunderson (Acad. Med. 2009;84:1348-51) emphasizes the need to train physicians to provide leadership for the future management of the hospital. He points out that in 1935, physicians were in charge of 35% of the nation's hospitals, but that number has shrunk to 4% of our current 6,500 U.S. hospitals. The academic medical community has largely ignored its role in preparing medical students for administrative leadership as it focused on the clinical knowledge required for the medical competence.

Dr. Gunderson, of Indiana University in Indianapolis, advocates the identification of student leaders in the selection of medical students and proposes the inclusion of courses in medical finance and social issues in the medical school curriculum in order to prepare them for a leadership role in redefining the future of medical care and hospital management.

Amanda Goodall, Ph.D., a senior research fellow at the Institute for the Study of Labor in Bonn, Germany, provides an even more challenging analysis of the importance of medical leadership at the hospital (Social Science Med. 2011;73:535-9). She notes that these changes in leadership are not unique to the United States but also have taken place in European hospitals. Using a quality scoring system, she analyzed the quality performance of 100 of the U.S. News and World Report's Best Hospitals 2009 in the fields of cancer, digestive disorders, and heart and heart surgery. She found a positive correlation between hospital quality ranking and physician CEO leadership.

Those of us who have grown up through this management evolution have seen its real impact on the care of hospital patients. Some of the changes have been positive, while others have proved frustrating for both patients and physicians who practice in the new environment.

The need for leadership by those of us who have direct patient care responsibilities is essential for an inclusive decision-making process. When patient care comes to discussion at the board meeting, physicians and nurses bring to the process a perspective that only they can provide. It is essential that their voices be heard.

Over the past century, the management of American hospitals has changed dramatically. These changes have occurred as a result of major shifts in the social and financial environment and have had a major effect on how medicine was practiced in the past and how it will be practiced in the future.

The American hospital as we know it today was established in the late 19th and early 20th centuries largely by the Catholic, Protestant, and Jewish communities to provide care for the elderly and chronically ill patients who otherwise would not be cared for at home.

With the development of surgical techniques from tonsillectomies to cholecystectomies in the mid-20th century, they became the workshop of general surgeons, who largely controlled the hospitals. With the subsequent development of antibiotics and medical treatment for cardiovascular disease, the internal medicine specialties demanded a larger role in institutional management.

The increased complexity and expense of medical care led to concerns about how to provide a financial base for medical care and led to the establishment of private medical insurance programs, and ultimately, to Medicare and Medicaid. Hospitals were no longer concerned about being a health resource but suddenly became a profit center. Community hospitals expanded in order to meet the needs of new technologies with the support of grants and loans from the federal government.

With this growth, the management of the hospital of the 20th century required the creation of a new breed of hospital staff: the hospital administrator. They were hired to manage the financial and administrative aspects of these new and growing organizations. Although the hospital administration was structured to provide equipoise between the medical and financial priorities of the hospital, that balance was not easily maintained, and as the financial aspects became central, the hospital administrator became supreme and physicians lost control.

Today, the American hospital has become central to the support of nonprofit and for-profit regional and national health care conglomerates, and control has become the province of boards of directors with little medical input and larger community control. As a consequence, the physician has now become a real or quasi-employee of the hospital.

In a recent perspective paper, Dr. Richard Gunderson (Acad. Med. 2009;84:1348-51) emphasizes the need to train physicians to provide leadership for the future management of the hospital. He points out that in 1935, physicians were in charge of 35% of the nation's hospitals, but that number has shrunk to 4% of our current 6,500 U.S. hospitals. The academic medical community has largely ignored its role in preparing medical students for administrative leadership as it focused on the clinical knowledge required for the medical competence.

Dr. Gunderson, of Indiana University in Indianapolis, advocates the identification of student leaders in the selection of medical students and proposes the inclusion of courses in medical finance and social issues in the medical school curriculum in order to prepare them for a leadership role in redefining the future of medical care and hospital management.

Amanda Goodall, Ph.D., a senior research fellow at the Institute for the Study of Labor in Bonn, Germany, provides an even more challenging analysis of the importance of medical leadership at the hospital (Social Science Med. 2011;73:535-9). She notes that these changes in leadership are not unique to the United States but also have taken place in European hospitals. Using a quality scoring system, she analyzed the quality performance of 100 of the U.S. News and World Report's Best Hospitals 2009 in the fields of cancer, digestive disorders, and heart and heart surgery. She found a positive correlation between hospital quality ranking and physician CEO leadership.

Those of us who have grown up through this management evolution have seen its real impact on the care of hospital patients. Some of the changes have been positive, while others have proved frustrating for both patients and physicians who practice in the new environment.

The need for leadership by those of us who have direct patient care responsibilities is essential for an inclusive decision-making process. When patient care comes to discussion at the board meeting, physicians and nurses bring to the process a perspective that only they can provide. It is essential that their voices be heard.

Over the past century, the management of American hospitals has changed dramatically. These changes have occurred as a result of major shifts in the social and financial environment and have had a major effect on how medicine was practiced in the past and how it will be practiced in the future.

The American hospital as we know it today was established in the late 19th and early 20th centuries largely by the Catholic, Protestant, and Jewish communities to provide care for the elderly and chronically ill patients who otherwise would not be cared for at home.

With the development of surgical techniques from tonsillectomies to cholecystectomies in the mid-20th century, they became the workshop of general surgeons, who largely controlled the hospitals. With the subsequent development of antibiotics and medical treatment for cardiovascular disease, the internal medicine specialties demanded a larger role in institutional management.

The increased complexity and expense of medical care led to concerns about how to provide a financial base for medical care and led to the establishment of private medical insurance programs, and ultimately, to Medicare and Medicaid. Hospitals were no longer concerned about being a health resource but suddenly became a profit center. Community hospitals expanded in order to meet the needs of new technologies with the support of grants and loans from the federal government.

With this growth, the management of the hospital of the 20th century required the creation of a new breed of hospital staff: the hospital administrator. They were hired to manage the financial and administrative aspects of these new and growing organizations. Although the hospital administration was structured to provide equipoise between the medical and financial priorities of the hospital, that balance was not easily maintained, and as the financial aspects became central, the hospital administrator became supreme and physicians lost control.

Today, the American hospital has become central to the support of nonprofit and for-profit regional and national health care conglomerates, and control has become the province of boards of directors with little medical input and larger community control. As a consequence, the physician has now become a real or quasi-employee of the hospital.

In a recent perspective paper, Dr. Richard Gunderson (Acad. Med. 2009;84:1348-51) emphasizes the need to train physicians to provide leadership for the future management of the hospital. He points out that in 1935, physicians were in charge of 35% of the nation's hospitals, but that number has shrunk to 4% of our current 6,500 U.S. hospitals. The academic medical community has largely ignored its role in preparing medical students for administrative leadership as it focused on the clinical knowledge required for the medical competence.

Dr. Gunderson, of Indiana University in Indianapolis, advocates the identification of student leaders in the selection of medical students and proposes the inclusion of courses in medical finance and social issues in the medical school curriculum in order to prepare them for a leadership role in redefining the future of medical care and hospital management.

Amanda Goodall, Ph.D., a senior research fellow at the Institute for the Study of Labor in Bonn, Germany, provides an even more challenging analysis of the importance of medical leadership at the hospital (Social Science Med. 2011;73:535-9). She notes that these changes in leadership are not unique to the United States but also have taken place in European hospitals. Using a quality scoring system, she analyzed the quality performance of 100 of the U.S. News and World Report's Best Hospitals 2009 in the fields of cancer, digestive disorders, and heart and heart surgery. She found a positive correlation between hospital quality ranking and physician CEO leadership.

Those of us who have grown up through this management evolution have seen its real impact on the care of hospital patients. Some of the changes have been positive, while others have proved frustrating for both patients and physicians who practice in the new environment.

The need for leadership by those of us who have direct patient care responsibilities is essential for an inclusive decision-making process. When patient care comes to discussion at the board meeting, physicians and nurses bring to the process a perspective that only they can provide. It is essential that their voices be heard.

The recent Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD AF) provides further data to belie our obsession with obtaining or maintaining normal sinus rhythm in patients with intermittent or paroxysmal AF (J. Am. Coll. Cardiol. 2011;58:493-501).

Registry studies fail to provide the randomized data that we demand in control trials, but can often yield data about real-world therapy. This registry, which included 5,604 patients from around the world and whose authors were either consultants or employees of Sanofi-Aventis, the makers of dronedarone, confirms much of what has already been said on the issue. There is little or no benefit associated with the rhythm control therapy compared to a heart rate strategy when examined in this community-based unselected population.

Because patients in this study were not randomized to a particular therapy, participating doctors could use either strategy. Unfortunately, patients in the rate control arm were older and more often had AF, heart failure, and valvular heart disease at baseline. Despite this imbalance, the heart rate strategy was as good as rhythm control. Both groups experienced an 18% incidence of adverse clinical events that were determined by the clinical characteristics of the patient and not the therapeutic strategy used or heart rate achieved. Success was measured by the presence of normal sinus rhythm in the rhythm-controlled patients or a heart rate of less than 80 bpm in the rate-controlled patients at 1 year follow-up, which was achieved in 60% and 47%, respectively. If the heart rate target was below 85 bpm, the success was achieved in 60% vs. 52%, respectively. These observations are consistent with previous studies comparing rhythm and rate control strategies.

This obsession with the maintenance of normal sinus rhythm in patients with AF has spawned a whole industry associated with the technology and application of catheter ablation, atrial defibrillation, left atrial occlusive devices, and the continued development of anti-arrhythmic drugs. All of these interventions have achieved some success but have been associated with significant drug and device adverse events.

The most recently approved anti-arrhythmic drug, dronedarone (Multaq), has been extensively studied in AF. Three major clinical trials have examined the drug in paroxysmal, persistent, and permanent AF. The most recent trial, Permanent Atrial Fibrillation Outcome Study Using Dronedarone (PALLAS), compared dronedarone to placebo in 3,000 patients with permanent AF and who also had a number of comorbidities, including symptomatic heart failure and a decrease in ejection fraction, but excluded New York Heart Association class III heart failure. Only an electrophysiologist is able to make the distinction between these two clinical heart failure settings. The study was prematurely stopped because of a significant increase in cardiovascular events, including mortality (

Dronedarone was approved in 2009 for patients with paroxysmal and persistent AF and atrial flutter by the Food and Drug Administration based on the ATHENA trial, which reported a decrease in recurrent AF in patients treated with the drug. In addition, dronedarone decreased the combined cardiovascular end point of mortality and rehospitalization, achieved mostly by a decrease in rehospitalization. However, its approval included a boxed warning that it is “contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization,” because of the increased risks observed in the previous Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA). That trial, which included mostly patients with NYHA class III-IV, was stopped prematurely because of the increase in heart failure mortality.

Dr. Stuart Connolly, the co–primary investigator of PALLAS, emphasized the difference between ATHENA, which randomized patients with nonpermanent AF, and PALLAS, which randomized patients with permanent AF. He thought that it was “reasonable” for patients with nonpermanent AF to continue with dronedarone, because “they will still benefit from it in terms of reduced CV hospitalization.”

Although there are surely some patients in whom AF causes significant symptoms that warrant aggressive therapy, the vast majority of patients, as indicated in RECORD AF, tolerate AF quite well. Much of the quest for rhythm control is related to the need to prevent systemic emboli and the requirement for anticoagulation therapy using vitamin K derivatives. The development of new antithrombotic drugs and factor Xa inhibitors now provides a safer and more effective alternative. It is time to relax our obsessive approach to atrial fibrillation therapy and become more realistic about our long-term goals for its therapy.

The recent Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD AF) provides further data to belie our obsession with obtaining or maintaining normal sinus rhythm in patients with intermittent or paroxysmal AF (J. Am. Coll. Cardiol. 2011;58:493-501).

Registry studies fail to provide the randomized data that we demand in control trials, but can often yield data about real-world therapy. This registry, which included 5,604 patients from around the world and whose authors were either consultants or employees of Sanofi-Aventis, the makers of dronedarone, confirms much of what has already been said on the issue. There is little or no benefit associated with the rhythm control therapy compared to a heart rate strategy when examined in this community-based unselected population.

Because patients in this study were not randomized to a particular therapy, participating doctors could use either strategy. Unfortunately, patients in the rate control arm were older and more often had AF, heart failure, and valvular heart disease at baseline. Despite this imbalance, the heart rate strategy was as good as rhythm control. Both groups experienced an 18% incidence of adverse clinical events that were determined by the clinical characteristics of the patient and not the therapeutic strategy used or heart rate achieved. Success was measured by the presence of normal sinus rhythm in the rhythm-controlled patients or a heart rate of less than 80 bpm in the rate-controlled patients at 1 year follow-up, which was achieved in 60% and 47%, respectively. If the heart rate target was below 85 bpm, the success was achieved in 60% vs. 52%, respectively. These observations are consistent with previous studies comparing rhythm and rate control strategies.

This obsession with the maintenance of normal sinus rhythm in patients with AF has spawned a whole industry associated with the technology and application of catheter ablation, atrial defibrillation, left atrial occlusive devices, and the continued development of anti-arrhythmic drugs. All of these interventions have achieved some success but have been associated with significant drug and device adverse events.

The most recently approved anti-arrhythmic drug, dronedarone (Multaq), has been extensively studied in AF. Three major clinical trials have examined the drug in paroxysmal, persistent, and permanent AF. The most recent trial, Permanent Atrial Fibrillation Outcome Study Using Dronedarone (PALLAS), compared dronedarone to placebo in 3,000 patients with permanent AF and who also had a number of comorbidities, including symptomatic heart failure and a decrease in ejection fraction, but excluded New York Heart Association class III heart failure. Only an electrophysiologist is able to make the distinction between these two clinical heart failure settings. The study was prematurely stopped because of a significant increase in cardiovascular events, including mortality (

Dronedarone was approved in 2009 for patients with paroxysmal and persistent AF and atrial flutter by the Food and Drug Administration based on the ATHENA trial, which reported a decrease in recurrent AF in patients treated with the drug. In addition, dronedarone decreased the combined cardiovascular end point of mortality and rehospitalization, achieved mostly by a decrease in rehospitalization. However, its approval included a boxed warning that it is “contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization,” because of the increased risks observed in the previous Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA). That trial, which included mostly patients with NYHA class III-IV, was stopped prematurely because of the increase in heart failure mortality.

Dr. Stuart Connolly, the co–primary investigator of PALLAS, emphasized the difference between ATHENA, which randomized patients with nonpermanent AF, and PALLAS, which randomized patients with permanent AF. He thought that it was “reasonable” for patients with nonpermanent AF to continue with dronedarone, because “they will still benefit from it in terms of reduced CV hospitalization.”

Although there are surely some patients in whom AF causes significant symptoms that warrant aggressive therapy, the vast majority of patients, as indicated in RECORD AF, tolerate AF quite well. Much of the quest for rhythm control is related to the need to prevent systemic emboli and the requirement for anticoagulation therapy using vitamin K derivatives. The development of new antithrombotic drugs and factor Xa inhibitors now provides a safer and more effective alternative. It is time to relax our obsessive approach to atrial fibrillation therapy and become more realistic about our long-term goals for its therapy.

The recent Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD AF) provides further data to belie our obsession with obtaining or maintaining normal sinus rhythm in patients with intermittent or paroxysmal AF (J. Am. Coll. Cardiol. 2011;58:493-501).

Registry studies fail to provide the randomized data that we demand in control trials, but can often yield data about real-world therapy. This registry, which included 5,604 patients from around the world and whose authors were either consultants or employees of Sanofi-Aventis, the makers of dronedarone, confirms much of what has already been said on the issue. There is little or no benefit associated with the rhythm control therapy compared to a heart rate strategy when examined in this community-based unselected population.

Because patients in this study were not randomized to a particular therapy, participating doctors could use either strategy. Unfortunately, patients in the rate control arm were older and more often had AF, heart failure, and valvular heart disease at baseline. Despite this imbalance, the heart rate strategy was as good as rhythm control. Both groups experienced an 18% incidence of adverse clinical events that were determined by the clinical characteristics of the patient and not the therapeutic strategy used or heart rate achieved. Success was measured by the presence of normal sinus rhythm in the rhythm-controlled patients or a heart rate of less than 80 bpm in the rate-controlled patients at 1 year follow-up, which was achieved in 60% and 47%, respectively. If the heart rate target was below 85 bpm, the success was achieved in 60% vs. 52%, respectively. These observations are consistent with previous studies comparing rhythm and rate control strategies.

This obsession with the maintenance of normal sinus rhythm in patients with AF has spawned a whole industry associated with the technology and application of catheter ablation, atrial defibrillation, left atrial occlusive devices, and the continued development of anti-arrhythmic drugs. All of these interventions have achieved some success but have been associated with significant drug and device adverse events.

The most recently approved anti-arrhythmic drug, dronedarone (Multaq), has been extensively studied in AF. Three major clinical trials have examined the drug in paroxysmal, persistent, and permanent AF. The most recent trial, Permanent Atrial Fibrillation Outcome Study Using Dronedarone (PALLAS), compared dronedarone to placebo in 3,000 patients with permanent AF and who also had a number of comorbidities, including symptomatic heart failure and a decrease in ejection fraction, but excluded New York Heart Association class III heart failure. Only an electrophysiologist is able to make the distinction between these two clinical heart failure settings. The study was prematurely stopped because of a significant increase in cardiovascular events, including mortality (

Dronedarone was approved in 2009 for patients with paroxysmal and persistent AF and atrial flutter by the Food and Drug Administration based on the ATHENA trial, which reported a decrease in recurrent AF in patients treated with the drug. In addition, dronedarone decreased the combined cardiovascular end point of mortality and rehospitalization, achieved mostly by a decrease in rehospitalization. However, its approval included a boxed warning that it is “contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization,” because of the increased risks observed in the previous Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA). That trial, which included mostly patients with NYHA class III-IV, was stopped prematurely because of the increase in heart failure mortality.

Dr. Stuart Connolly, the co–primary investigator of PALLAS, emphasized the difference between ATHENA, which randomized patients with nonpermanent AF, and PALLAS, which randomized patients with permanent AF. He thought that it was “reasonable” for patients with nonpermanent AF to continue with dronedarone, because “they will still benefit from it in terms of reduced CV hospitalization.”

Although there are surely some patients in whom AF causes significant symptoms that warrant aggressive therapy, the vast majority of patients, as indicated in RECORD AF, tolerate AF quite well. Much of the quest for rhythm control is related to the need to prevent systemic emboli and the requirement for anticoagulation therapy using vitamin K derivatives. The development of new antithrombotic drugs and factor Xa inhibitors now provides a safer and more effective alternative. It is time to relax our obsessive approach to atrial fibrillation therapy and become more realistic about our long-term goals for its therapy.

They came for a second opinion. They were both in their 50s; she a lawyer, the husband a stockbroker. He had insulin dependent diabetes for 20 years but was otherwise well. She was concerned that her husband would die suddenly just as his father had at age 70. He was without symptoms but had a nuclear exercise stress test at the behest of his local medical doctor because of his diabetes.

The test was said to be abnormal, but three subsequent in-house readers found the results normal. He was advised to have an angiogram by another cardiologist. “What should we do?”

I told her that an angiogram or a stent would not prevent him from dying suddenly. I outlined all the pros and cons and advised against it. The wife was very anxious and wanted an angiogram so that her husband wouldn't die suddenly. They both left my office, never to be seen again.

A recent report by Dr. William B. Borden and colleagues (JAMA 2011;305:1882-9) examined the change in clinical practice in regard to percutaneous coronary intervention before and after the report of the COURAGE trial 4 years ago (N. Engl. J. Med. 2007;356:1503-16), which indicated that there was no mortality or morbidity benefit in patients with stable angina who received PCI when compared to optimal medical therapy.

Dr. Borden and colleagues presumed that the results of the COURAGE trial would transform clinical practice, and that most of the 293,795 patients in their study who went on to PCI in the COURAGE-like population would receive optimal medical therapy before PCI.

In fact, optimal medical therapy (defined as therapy with aspirin, a beta-blocker, an ACE inhibitor, and a statin) was used in 43.4% of the patients before COURAGE and in 45.0% after the COURAGE report. In COURAGE, 32% had diabetes, 12% of the patients were asymptomatic, and 30% had class I angina.

In the most recent analysis by Dr. Borden, one-third of patients (more than 70,000) had no angina prior to PCI. One must wonder what the perceived patient benefit was that led to the performance of a PCI in those patients.

My patient's other cardiologist advised angiography for my patient partly because of a concern for the early identification of ischemic heart disease in diabetic patients. Indeed, this concern had led the American Diabetes Association to recommend that in addition to standard secondary prevention therapy for both diabetes and coronary artery disease, patients with two or more risk factors for coronary artery disease undergo early screening (Diabetes Care 1998;13:1551-9).

These recommendations, however, were not evidence based, but made on the recommendation of an expert panel. The DIAD (Detection of Ischemia in Asymptomatic Diabetics) trial has since provided further insight into the issue of screening asymptomatic diabetic patients (JAMA 2009;301:1547-55), an issue that remains controversial.

Although not a randomized trial, DIAD indicates that the event rate in asymptomatic diabetic patients in general is low, and that a positive myocardial perfusion stress test did not identify patients who were at an increase risk of ischemic events.

Of the 522 asymptomatic patients screened, 409 (78%) had normal results, 50 (10%) had a small perfusion defect, and 33 (6%) had moderate or large perfusion defects. Although there was no significantly increased risk of cardiac events in patients with small defects when they were compared with those who had no perfusion defect, there was a sixfold increase risk in patients with moderate to large defects on myocardial perfusion imaging. Only 4.4% of patients went on to angiography, a decision driven by the clinical judgment of the patient's physician.

Of course, in my example, the greatest pressure for angiography came from the patient's wife, who was convinced that on the basis of conventional wisdom, myocardial perfusion imaging–guided PCI would identify a critical lesion that, when treated with PCI, would prolong her husband's life. And as a matter of fact, in order to prove the absence of coronary artery disease based on the normal perfusion test, I agreed to arrange an angiogram should they need reassurance that the test was normal. What would have eventuated should we have found a lesion remains for your conjecture.

But it is clear that there is an overabundance of angiograms being performed in asymptomatic patients, which more than likely leads to the performance of unnecessary PCIs in asymptomatic patients. Angiography has become the “carpenter's hammer,” with the little regard for its benefit.

A more reasonable and effective approach to diabetes patients (as well as other asymptomatic patients) is the institution of adequate primary prevention, which has been shown to have both morbidity and mortality benefits.

They came for a second opinion. They were both in their 50s; she a lawyer, the husband a stockbroker. He had insulin dependent diabetes for 20 years but was otherwise well. She was concerned that her husband would die suddenly just as his father had at age 70. He was without symptoms but had a nuclear exercise stress test at the behest of his local medical doctor because of his diabetes.

The test was said to be abnormal, but three subsequent in-house readers found the results normal. He was advised to have an angiogram by another cardiologist. “What should we do?”

I told her that an angiogram or a stent would not prevent him from dying suddenly. I outlined all the pros and cons and advised against it. The wife was very anxious and wanted an angiogram so that her husband wouldn't die suddenly. They both left my office, never to be seen again.

A recent report by Dr. William B. Borden and colleagues (JAMA 2011;305:1882-9) examined the change in clinical practice in regard to percutaneous coronary intervention before and after the report of the COURAGE trial 4 years ago (N. Engl. J. Med. 2007;356:1503-16), which indicated that there was no mortality or morbidity benefit in patients with stable angina who received PCI when compared to optimal medical therapy.

Dr. Borden and colleagues presumed that the results of the COURAGE trial would transform clinical practice, and that most of the 293,795 patients in their study who went on to PCI in the COURAGE-like population would receive optimal medical therapy before PCI.

In fact, optimal medical therapy (defined as therapy with aspirin, a beta-blocker, an ACE inhibitor, and a statin) was used in 43.4% of the patients before COURAGE and in 45.0% after the COURAGE report. In COURAGE, 32% had diabetes, 12% of the patients were asymptomatic, and 30% had class I angina.

In the most recent analysis by Dr. Borden, one-third of patients (more than 70,000) had no angina prior to PCI. One must wonder what the perceived patient benefit was that led to the performance of a PCI in those patients.

My patient's other cardiologist advised angiography for my patient partly because of a concern for the early identification of ischemic heart disease in diabetic patients. Indeed, this concern had led the American Diabetes Association to recommend that in addition to standard secondary prevention therapy for both diabetes and coronary artery disease, patients with two or more risk factors for coronary artery disease undergo early screening (Diabetes Care 1998;13:1551-9).

These recommendations, however, were not evidence based, but made on the recommendation of an expert panel. The DIAD (Detection of Ischemia in Asymptomatic Diabetics) trial has since provided further insight into the issue of screening asymptomatic diabetic patients (JAMA 2009;301:1547-55), an issue that remains controversial.

Although not a randomized trial, DIAD indicates that the event rate in asymptomatic diabetic patients in general is low, and that a positive myocardial perfusion stress test did not identify patients who were at an increase risk of ischemic events.

Of the 522 asymptomatic patients screened, 409 (78%) had normal results, 50 (10%) had a small perfusion defect, and 33 (6%) had moderate or large perfusion defects. Although there was no significantly increased risk of cardiac events in patients with small defects when they were compared with those who had no perfusion defect, there was a sixfold increase risk in patients with moderate to large defects on myocardial perfusion imaging. Only 4.4% of patients went on to angiography, a decision driven by the clinical judgment of the patient's physician.

Of course, in my example, the greatest pressure for angiography came from the patient's wife, who was convinced that on the basis of conventional wisdom, myocardial perfusion imaging–guided PCI would identify a critical lesion that, when treated with PCI, would prolong her husband's life. And as a matter of fact, in order to prove the absence of coronary artery disease based on the normal perfusion test, I agreed to arrange an angiogram should they need reassurance that the test was normal. What would have eventuated should we have found a lesion remains for your conjecture.

But it is clear that there is an overabundance of angiograms being performed in asymptomatic patients, which more than likely leads to the performance of unnecessary PCIs in asymptomatic patients. Angiography has become the “carpenter's hammer,” with the little regard for its benefit.

A more reasonable and effective approach to diabetes patients (as well as other asymptomatic patients) is the institution of adequate primary prevention, which has been shown to have both morbidity and mortality benefits.

They came for a second opinion. They were both in their 50s; she a lawyer, the husband a stockbroker. He had insulin dependent diabetes for 20 years but was otherwise well. She was concerned that her husband would die suddenly just as his father had at age 70. He was without symptoms but had a nuclear exercise stress test at the behest of his local medical doctor because of his diabetes.

The test was said to be abnormal, but three subsequent in-house readers found the results normal. He was advised to have an angiogram by another cardiologist. “What should we do?”

I told her that an angiogram or a stent would not prevent him from dying suddenly. I outlined all the pros and cons and advised against it. The wife was very anxious and wanted an angiogram so that her husband wouldn't die suddenly. They both left my office, never to be seen again.

A recent report by Dr. William B. Borden and colleagues (JAMA 2011;305:1882-9) examined the change in clinical practice in regard to percutaneous coronary intervention before and after the report of the COURAGE trial 4 years ago (N. Engl. J. Med. 2007;356:1503-16), which indicated that there was no mortality or morbidity benefit in patients with stable angina who received PCI when compared to optimal medical therapy.

Dr. Borden and colleagues presumed that the results of the COURAGE trial would transform clinical practice, and that most of the 293,795 patients in their study who went on to PCI in the COURAGE-like population would receive optimal medical therapy before PCI.

In fact, optimal medical therapy (defined as therapy with aspirin, a beta-blocker, an ACE inhibitor, and a statin) was used in 43.4% of the patients before COURAGE and in 45.0% after the COURAGE report. In COURAGE, 32% had diabetes, 12% of the patients were asymptomatic, and 30% had class I angina.

In the most recent analysis by Dr. Borden, one-third of patients (more than 70,000) had no angina prior to PCI. One must wonder what the perceived patient benefit was that led to the performance of a PCI in those patients.

My patient's other cardiologist advised angiography for my patient partly because of a concern for the early identification of ischemic heart disease in diabetic patients. Indeed, this concern had led the American Diabetes Association to recommend that in addition to standard secondary prevention therapy for both diabetes and coronary artery disease, patients with two or more risk factors for coronary artery disease undergo early screening (Diabetes Care 1998;13:1551-9).

These recommendations, however, were not evidence based, but made on the recommendation of an expert panel. The DIAD (Detection of Ischemia in Asymptomatic Diabetics) trial has since provided further insight into the issue of screening asymptomatic diabetic patients (JAMA 2009;301:1547-55), an issue that remains controversial.

Although not a randomized trial, DIAD indicates that the event rate in asymptomatic diabetic patients in general is low, and that a positive myocardial perfusion stress test did not identify patients who were at an increase risk of ischemic events.

Of the 522 asymptomatic patients screened, 409 (78%) had normal results, 50 (10%) had a small perfusion defect, and 33 (6%) had moderate or large perfusion defects. Although there was no significantly increased risk of cardiac events in patients with small defects when they were compared with those who had no perfusion defect, there was a sixfold increase risk in patients with moderate to large defects on myocardial perfusion imaging. Only 4.4% of patients went on to angiography, a decision driven by the clinical judgment of the patient's physician.

Of course, in my example, the greatest pressure for angiography came from the patient's wife, who was convinced that on the basis of conventional wisdom, myocardial perfusion imaging–guided PCI would identify a critical lesion that, when treated with PCI, would prolong her husband's life. And as a matter of fact, in order to prove the absence of coronary artery disease based on the normal perfusion test, I agreed to arrange an angiogram should they need reassurance that the test was normal. What would have eventuated should we have found a lesion remains for your conjecture.

But it is clear that there is an overabundance of angiograms being performed in asymptomatic patients, which more than likely leads to the performance of unnecessary PCIs in asymptomatic patients. Angiography has become the “carpenter's hammer,” with the little regard for its benefit.

A more reasonable and effective approach to diabetes patients (as well as other asymptomatic patients) is the institution of adequate primary prevention, which has been shown to have both morbidity and mortality benefits.

When the National Heart, Lung, and Blood Institute announced that the Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health (AIM-HIGH) trial was being terminated because of the futility of showing benefit, the study's failure made front page news.

The medical community, patient population, and interested public ask “why?” at this unexpected result of the study that compared extended-release niacin (Niaspan) plus simvastatin with placebo plus simvastatin.

Cardiologists and lipidologists may be better able to answer this question when the full results are published. More information will certainly be required concerning the reported increase in stroke in the niacin arm (28 vs 12). At this stage, a hypothesis regarding the lack of benefit must be considered tentative at best.

However, the first thing that comes to mind is whether the study was sufficiently powered. A clinical trial currently underway at Oxford (England) University, HPS2-THRIVE, is comparing extended-release niacin and laropiprant (a prostaglandin receptor antagonist to decrease flushing approved in Europe but not the United States) against a background of simvastatin. HPS2-THRIVE aims to enroll 25,000 subjects, so this difference in size compared with AIM-HIGH must indicate large differences in expected event rate.

One should also bear in mind that the decrease in events reported with niacin in the Coronary Drug Project (J. Am. Coll. Cardiol. 1986;8:1245-55) was against a background of placebo. Statins have set a very high bar for efficacy, and it can be difficult to demonstrate incremental benefit with an add-on to statin therapy, as was the case in the ENHANCE trial with ezetimibe. In fact, there was substantial use of ezetimibe in the placebo group of AIM-HIGH, which therefore was not a true placebo group, in order to reach a target LDL cholesterol level of less than 80 mg/dL. This is somewhat ironic since niacin plus statin was reported to be more effective than ezetimibe plus statin in reducing carotid intima-media thickness in the ARBITER 6-HALTS study (N. Engl. J. Med. 2009;361:2113-22).

The National Lipid Association has recommended that physicians should wait until the full results of AIM-HIGH are reported before integrating the findings into their clinical practice, and that patients should not stop taking niacin without the advice of their physician.

I agree with this recommendation. It remains to be seen whether we will ever know the full explanation for the futility results of AIM-HIGH. We certainly will know much more when the results are analyzed and when HPS2-THRIVE is reported.

In the meantime, there are alternative ways of raising HDL currently being tested, including with the cholesteryl ester transfer protein (CETP) inhibitors anacetrapib and dalcetrapib, so the final results are far from complete concerning the benefit of raising HDL cholesterol, particularly in patients with low HDL cholesterol. AIM-HIGH does not disprove the theory that raising HDL will be beneficial, and there are abundant data showing that low HDL increases cardiovascular risk.

Hence, AIM-HIGH does not provide support for the “HDL hypothesis,” but neither does it drive the final nail in the coffin.

When the National Heart, Lung, and Blood Institute announced that the Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health (AIM-HIGH) trial was being terminated because of the futility of showing benefit, the study's failure made front page news.

The medical community, patient population, and interested public ask “why?” at this unexpected result of the study that compared extended-release niacin (Niaspan) plus simvastatin with placebo plus simvastatin.

Cardiologists and lipidologists may be better able to answer this question when the full results are published. More information will certainly be required concerning the reported increase in stroke in the niacin arm (28 vs 12). At this stage, a hypothesis regarding the lack of benefit must be considered tentative at best.

However, the first thing that comes to mind is whether the study was sufficiently powered. A clinical trial currently underway at Oxford (England) University, HPS2-THRIVE, is comparing extended-release niacin and laropiprant (a prostaglandin receptor antagonist to decrease flushing approved in Europe but not the United States) against a background of simvastatin. HPS2-THRIVE aims to enroll 25,000 subjects, so this difference in size compared with AIM-HIGH must indicate large differences in expected event rate.

One should also bear in mind that the decrease in events reported with niacin in the Coronary Drug Project (J. Am. Coll. Cardiol. 1986;8:1245-55) was against a background of placebo. Statins have set a very high bar for efficacy, and it can be difficult to demonstrate incremental benefit with an add-on to statin therapy, as was the case in the ENHANCE trial with ezetimibe. In fact, there was substantial use of ezetimibe in the placebo group of AIM-HIGH, which therefore was not a true placebo group, in order to reach a target LDL cholesterol level of less than 80 mg/dL. This is somewhat ironic since niacin plus statin was reported to be more effective than ezetimibe plus statin in reducing carotid intima-media thickness in the ARBITER 6-HALTS study (N. Engl. J. Med. 2009;361:2113-22).

The National Lipid Association has recommended that physicians should wait until the full results of AIM-HIGH are reported before integrating the findings into their clinical practice, and that patients should not stop taking niacin without the advice of their physician.

I agree with this recommendation. It remains to be seen whether we will ever know the full explanation for the futility results of AIM-HIGH. We certainly will know much more when the results are analyzed and when HPS2-THRIVE is reported.

In the meantime, there are alternative ways of raising HDL currently being tested, including with the cholesteryl ester transfer protein (CETP) inhibitors anacetrapib and dalcetrapib, so the final results are far from complete concerning the benefit of raising HDL cholesterol, particularly in patients with low HDL cholesterol. AIM-HIGH does not disprove the theory that raising HDL will be beneficial, and there are abundant data showing that low HDL increases cardiovascular risk.

Hence, AIM-HIGH does not provide support for the “HDL hypothesis,” but neither does it drive the final nail in the coffin.

When the National Heart, Lung, and Blood Institute announced that the Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health (AIM-HIGH) trial was being terminated because of the futility of showing benefit, the study's failure made front page news.

The medical community, patient population, and interested public ask “why?” at this unexpected result of the study that compared extended-release niacin (Niaspan) plus simvastatin with placebo plus simvastatin.

Cardiologists and lipidologists may be better able to answer this question when the full results are published. More information will certainly be required concerning the reported increase in stroke in the niacin arm (28 vs 12). At this stage, a hypothesis regarding the lack of benefit must be considered tentative at best.

However, the first thing that comes to mind is whether the study was sufficiently powered. A clinical trial currently underway at Oxford (England) University, HPS2-THRIVE, is comparing extended-release niacin and laropiprant (a prostaglandin receptor antagonist to decrease flushing approved in Europe but not the United States) against a background of simvastatin. HPS2-THRIVE aims to enroll 25,000 subjects, so this difference in size compared with AIM-HIGH must indicate large differences in expected event rate.

One should also bear in mind that the decrease in events reported with niacin in the Coronary Drug Project (J. Am. Coll. Cardiol. 1986;8:1245-55) was against a background of placebo. Statins have set a very high bar for efficacy, and it can be difficult to demonstrate incremental benefit with an add-on to statin therapy, as was the case in the ENHANCE trial with ezetimibe. In fact, there was substantial use of ezetimibe in the placebo group of AIM-HIGH, which therefore was not a true placebo group, in order to reach a target LDL cholesterol level of less than 80 mg/dL. This is somewhat ironic since niacin plus statin was reported to be more effective than ezetimibe plus statin in reducing carotid intima-media thickness in the ARBITER 6-HALTS study (N. Engl. J. Med. 2009;361:2113-22).

The National Lipid Association has recommended that physicians should wait until the full results of AIM-HIGH are reported before integrating the findings into their clinical practice, and that patients should not stop taking niacin without the advice of their physician.

I agree with this recommendation. It remains to be seen whether we will ever know the full explanation for the futility results of AIM-HIGH. We certainly will know much more when the results are analyzed and when HPS2-THRIVE is reported.

In the meantime, there are alternative ways of raising HDL currently being tested, including with the cholesteryl ester transfer protein (CETP) inhibitors anacetrapib and dalcetrapib, so the final results are far from complete concerning the benefit of raising HDL cholesterol, particularly in patients with low HDL cholesterol. AIM-HIGH does not disprove the theory that raising HDL will be beneficial, and there are abundant data showing that low HDL increases cardiovascular risk.

Hence, AIM-HIGH does not provide support for the “HDL hypothesis,” but neither does it drive the final nail in the coffin.

The natural history and pathology of aortic stenosis has been well described since the mid-18th century by John Baptist Morgagni. Its latency period usually runs 6-7 decades before expressing its classic symptoms. Once the symptoms of heart failure, angina, and syncope occur, the life span of patients is measured in 1-2 years.

Because of the increased number of octogenarians around these days, aortic stenosis has become a larger therapeutic problem to cardiologists. Unfortunately, when octogenarians come to the doctor with the symptoms of aortic stenosis, they usually bring a number of other comorbidities, such as coronary artery disease, diabetes, pulmonary insufficiency, and renal dysfunction, just to name a few. Surgical intervention in these patients carries high risk and both the patient and surgeon are reluctant to proceed with high-risk surgery in such a complex medical environment.

The recent development of a percutaneous aortic valve that can be implanted either transvenously or transapically has provided interesting options for these elderly patients. Several transcatheter aortic valves are now available in Europe, but until the last few months there have been no randomized clinical trials evaluating there efficacy.

The two most recent trials, the PARTNER trials, using a SAPIEN heart valve system (Edwards Lifesciences) have provided an opportunity to consider the potential benefits of transcatheter aortic-valve replacement (TAVR). The first reported trial compared TAVR to standard medical therapy in patients with severe aortic stenosis deemed inoperable for traditional aortic valve replacement (AVR). A second group of patient with severe aortic stenosis was randomized to either TAVR or AVR. Both studies have provided optimism that these percutaneous devices can provided significant benefit.

The initial PARTNER study randomized 358 stenosis patients who were considered to be inoperable, to either TAVR or standard medical therapy including in some case balloon aortic valvulotomy (N. Engl. J. Med. 2010; 363:1597-607). That trial reported a 30-day mortality of 5.0% and 2.8% and a 1-year mortality of 30.7% and 50.7% in the TAVR and standard medical therapy groups, respectively. Associated with this improvement in mortality, there was both symptomatic improvement and decrease in hospitalization in the TAVR treated patients. There was, however, an increase occurrence of major strokes, at 5.0% in the TAVR patients compared with 1.1% in the medical patients.

The most recent PARTNER trial reported at the annual meeting of the American Cardiology compared TAVR to standard surgical AVR in patients with severe aortic stenosis. In that trial, 699 patients with mean aortic valve area of 0.6-0.7 cm

The device used in PARTNER is currently approved for use in Europe and soon to be available in the United States. Several other transcatheter valve systems are currently in development by device companies, and one, the CoreValve (Medtronics) is currently undergoing clinical trials in the United States. The devices included in the early trials have been improved upon and investigators using the Edwards Lifesciences device are currently testing the fourth generation of that valve, which is smaller and easier to pass through the femoral artery.

In addition, protection devices are being developed to deal with the observed increased stroke morbidity. Although stroke remains a problem, emboli have not been limited to the brain but some reports suggest that, there is evidence for intracoronary embolism.

The development of these valves are obviously on the fast track but unfortunately little is known about their long-term durability. There are some follow-up data from Europe where the valve has been in use for about 2 years. When weighed against the years of experience and the excellent durability of the current AVR there should be some reticence to the application of these valves in patients at better surgical risks.

Although the operative risks for either TAVR or AVR are acceptable, considering the natural history of the disease, unfortunately the long-term risks of the elderly patients with aortic stenosis remains high even after successful valve replacement.

The natural history and pathology of aortic stenosis has been well described since the mid-18th century by John Baptist Morgagni. Its latency period usually runs 6-7 decades before expressing its classic symptoms. Once the symptoms of heart failure, angina, and syncope occur, the life span of patients is measured in 1-2 years.

Because of the increased number of octogenarians around these days, aortic stenosis has become a larger therapeutic problem to cardiologists. Unfortunately, when octogenarians come to the doctor with the symptoms of aortic stenosis, they usually bring a number of other comorbidities, such as coronary artery disease, diabetes, pulmonary insufficiency, and renal dysfunction, just to name a few. Surgical intervention in these patients carries high risk and both the patient and surgeon are reluctant to proceed with high-risk surgery in such a complex medical environment.

The recent development of a percutaneous aortic valve that can be implanted either transvenously or transapically has provided interesting options for these elderly patients. Several transcatheter aortic valves are now available in Europe, but until the last few months there have been no randomized clinical trials evaluating there efficacy.

The two most recent trials, the PARTNER trials, using a SAPIEN heart valve system (Edwards Lifesciences) have provided an opportunity to consider the potential benefits of transcatheter aortic-valve replacement (TAVR). The first reported trial compared TAVR to standard medical therapy in patients with severe aortic stenosis deemed inoperable for traditional aortic valve replacement (AVR). A second group of patient with severe aortic stenosis was randomized to either TAVR or AVR. Both studies have provided optimism that these percutaneous devices can provided significant benefit.

The initial PARTNER study randomized 358 stenosis patients who were considered to be inoperable, to either TAVR or standard medical therapy including in some case balloon aortic valvulotomy (N. Engl. J. Med. 2010; 363:1597-607). That trial reported a 30-day mortality of 5.0% and 2.8% and a 1-year mortality of 30.7% and 50.7% in the TAVR and standard medical therapy groups, respectively. Associated with this improvement in mortality, there was both symptomatic improvement and decrease in hospitalization in the TAVR treated patients. There was, however, an increase occurrence of major strokes, at 5.0% in the TAVR patients compared with 1.1% in the medical patients.

The most recent PARTNER trial reported at the annual meeting of the American Cardiology compared TAVR to standard surgical AVR in patients with severe aortic stenosis. In that trial, 699 patients with mean aortic valve area of 0.6-0.7 cm

The device used in PARTNER is currently approved for use in Europe and soon to be available in the United States. Several other transcatheter valve systems are currently in development by device companies, and one, the CoreValve (Medtronics) is currently undergoing clinical trials in the United States. The devices included in the early trials have been improved upon and investigators using the Edwards Lifesciences device are currently testing the fourth generation of that valve, which is smaller and easier to pass through the femoral artery.

In addition, protection devices are being developed to deal with the observed increased stroke morbidity. Although stroke remains a problem, emboli have not been limited to the brain but some reports suggest that, there is evidence for intracoronary embolism.

The development of these valves are obviously on the fast track but unfortunately little is known about their long-term durability. There are some follow-up data from Europe where the valve has been in use for about 2 years. When weighed against the years of experience and the excellent durability of the current AVR there should be some reticence to the application of these valves in patients at better surgical risks.

Although the operative risks for either TAVR or AVR are acceptable, considering the natural history of the disease, unfortunately the long-term risks of the elderly patients with aortic stenosis remains high even after successful valve replacement.

The natural history and pathology of aortic stenosis has been well described since the mid-18th century by John Baptist Morgagni. Its latency period usually runs 6-7 decades before expressing its classic symptoms. Once the symptoms of heart failure, angina, and syncope occur, the life span of patients is measured in 1-2 years.

Because of the increased number of octogenarians around these days, aortic stenosis has become a larger therapeutic problem to cardiologists. Unfortunately, when octogenarians come to the doctor with the symptoms of aortic stenosis, they usually bring a number of other comorbidities, such as coronary artery disease, diabetes, pulmonary insufficiency, and renal dysfunction, just to name a few. Surgical intervention in these patients carries high risk and both the patient and surgeon are reluctant to proceed with high-risk surgery in such a complex medical environment.

The recent development of a percutaneous aortic valve that can be implanted either transvenously or transapically has provided interesting options for these elderly patients. Several transcatheter aortic valves are now available in Europe, but until the last few months there have been no randomized clinical trials evaluating there efficacy.

The two most recent trials, the PARTNER trials, using a SAPIEN heart valve system (Edwards Lifesciences) have provided an opportunity to consider the potential benefits of transcatheter aortic-valve replacement (TAVR). The first reported trial compared TAVR to standard medical therapy in patients with severe aortic stenosis deemed inoperable for traditional aortic valve replacement (AVR). A second group of patient with severe aortic stenosis was randomized to either TAVR or AVR. Both studies have provided optimism that these percutaneous devices can provided significant benefit.

The initial PARTNER study randomized 358 stenosis patients who were considered to be inoperable, to either TAVR or standard medical therapy including in some case balloon aortic valvulotomy (N. Engl. J. Med. 2010; 363:1597-607). That trial reported a 30-day mortality of 5.0% and 2.8% and a 1-year mortality of 30.7% and 50.7% in the TAVR and standard medical therapy groups, respectively. Associated with this improvement in mortality, there was both symptomatic improvement and decrease in hospitalization in the TAVR treated patients. There was, however, an increase occurrence of major strokes, at 5.0% in the TAVR patients compared with 1.1% in the medical patients.

The most recent PARTNER trial reported at the annual meeting of the American Cardiology compared TAVR to standard surgical AVR in patients with severe aortic stenosis. In that trial, 699 patients with mean aortic valve area of 0.6-0.7 cm

The device used in PARTNER is currently approved for use in Europe and soon to be available in the United States. Several other transcatheter valve systems are currently in development by device companies, and one, the CoreValve (Medtronics) is currently undergoing clinical trials in the United States. The devices included in the early trials have been improved upon and investigators using the Edwards Lifesciences device are currently testing the fourth generation of that valve, which is smaller and easier to pass through the femoral artery.

In addition, protection devices are being developed to deal with the observed increased stroke morbidity. Although stroke remains a problem, emboli have not been limited to the brain but some reports suggest that, there is evidence for intracoronary embolism.

The development of these valves are obviously on the fast track but unfortunately little is known about their long-term durability. There are some follow-up data from Europe where the valve has been in use for about 2 years. When weighed against the years of experience and the excellent durability of the current AVR there should be some reticence to the application of these valves in patients at better surgical risks.

Although the operative risks for either TAVR or AVR are acceptable, considering the natural history of the disease, unfortunately the long-term risks of the elderly patients with aortic stenosis remains high even after successful valve replacement.

Coronary revascularization using bypass grafting with arterial or venous conduits has been with us since 1968 when Dr. Rene Favaloro performed the first saphenous venous graft for the treatment of angina pectoris (J. Thorac. Cardiovasc. Surg. 1969;58:178-85). Although it is clear that coronary artery bypass grafting (CABG) has been effective in decreasing symptomatic angina, with few exceptions there has been little to support its benefit in prolonging life. One of those exceptions was identified in a subgroup of the initial Coronary Artery Surgery Study carried out in the 1980s and sponsored by the National Heart, Lung, and Blood Institute (N. Engl. J. Med. 1985;312:1665-71). Of the 780 patients with chronic stable angina randomized to medicine only or CABG, there was a significant decrease in both angina and mortality in a subgroup of 160 patients with ejection fractions below 50%, primarily in patients with triple-vessel disease.

Since that report in 1985, there have been no clinical mortality trials examining the clinical benefit of CABG surgery in patients with ischemic heart failure. A randomized trial to evaluate the benefit of surgical ventricular reconstruction plus CABG, compared with CABG alone, failed to observe any benefit (N. Engl. J. Med. 2009:360;1705-17).

The suggestion that CABG could improve ventricular function is based on the observations by Dr. Shahbudin Rahimtoola in the 1980s in studies showing improved function in patients before and after CABG (Am. Heart J. 1989;117:211-21). He proposed the concept that areas of “hibernating myocardium” exist in the ischemic ventricle that can be revived by restoring its blood supply by CABG. But to a large degree, patients with ischemic heart failure have not been a prime target for CABG, and attempts to show clinical benefit in symptomatic improvement in heart failure has not been explored.

The recent report of the Surgical Treatment for Ischemic Heart Failure (STICH) trial has provided important information supporting the mortality and morbidity benefit of revascularization in patients with symptomatic ischemic heart failure (N. Engl. J. Med. 2011;364:1607-16). This study, also supported by NHLBI, was carried out in 26 countries throughout the world. In the 1,212 patients randomized to standard medical therapy alone, compared with medical therapy plus CABG, there was no significant benefit observed in the CABG patients in all-cause mortality, but there was a 19% decrease in cardiovascular mortality (P = .05) over a 3-year mean follow-up, and a 26% decrease in all-cause mortality and cardiovascular hospitalization (P less than .001). When patients who received CABG either by random assignment or because they were crossed over to surgery (620) were compared with those patients who remained on medical therapy (592), the effects of surgery were even more impressive, with a 30% decrease in all-cause mortality (P less than .001). The patients included in STICH were severely symptomatic, almost all with significant angina and 37% in NYHA HF class III/IV with a mean ejection fraction of 27%. Surgery carried an early up-front mortality risk of approximately 4%, which took about 2 years to overcome.

One interesting additional aspect of STICH was the viability study carried out in a subset of 601 patients using either dobutamine echocardiograms or SPECT stress testing. Although patients who demonstrated viability had a better outcome, viability did not define those patients who would benefit by CABG (N. Engl. J. Med. 2011;364:1617-25).

The “backstory” of the STICH trial was the failure of the U.S. cardiothoracic surgery centers to participate in it in a significant way. A total of 26 countries were required to achieve the 2,136 patients enrolled in the total STICH trial, and only 307 patients (14%) were American. The failure of the academic and large clinical centers to grasp the importance of this trial, and their reluctance to participate, was unfortunate.

The results of STICH indicate that the addition of CABG to patients already receiving optimal medical therapy provides a significant mortality and morbidity benefit. Unfortunately, viability studies do not provide helpful information in regard to the optimal selection of patients for CABG in ischemic heart failure. That decision appears to depend upon the availability of acceptable target vessels. But the data do support CABG, performed with an acceptable risk in experienced hands, as providing long-term benefits for heart failure patients.

Revascularization provides an additional mode of therapy for the treatment of patients with symptomatic ischemic heart failure, which could become a potential therapeutic target for percutaneous intervention in patients with the appropriate anatomy.

Coronary revascularization using bypass grafting with arterial or venous conduits has been with us since 1968 when Dr. Rene Favaloro performed the first saphenous venous graft for the treatment of angina pectoris (J. Thorac. Cardiovasc. Surg. 1969;58:178-85). Although it is clear that coronary artery bypass grafting (CABG) has been effective in decreasing symptomatic angina, with few exceptions there has been little to support its benefit in prolonging life. One of those exceptions was identified in a subgroup of the initial Coronary Artery Surgery Study carried out in the 1980s and sponsored by the National Heart, Lung, and Blood Institute (N. Engl. J. Med. 1985;312:1665-71). Of the 780 patients with chronic stable angina randomized to medicine only or CABG, there was a significant decrease in both angina and mortality in a subgroup of 160 patients with ejection fractions below 50%, primarily in patients with triple-vessel disease.

Since that report in 1985, there have been no clinical mortality trials examining the clinical benefit of CABG surgery in patients with ischemic heart failure. A randomized trial to evaluate the benefit of surgical ventricular reconstruction plus CABG, compared with CABG alone, failed to observe any benefit (N. Engl. J. Med. 2009:360;1705-17).

The suggestion that CABG could improve ventricular function is based on the observations by Dr. Shahbudin Rahimtoola in the 1980s in studies showing improved function in patients before and after CABG (Am. Heart J. 1989;117:211-21). He proposed the concept that areas of “hibernating myocardium” exist in the ischemic ventricle that can be revived by restoring its blood supply by CABG. But to a large degree, patients with ischemic heart failure have not been a prime target for CABG, and attempts to show clinical benefit in symptomatic improvement in heart failure has not been explored.

The recent report of the Surgical Treatment for Ischemic Heart Failure (STICH) trial has provided important information supporting the mortality and morbidity benefit of revascularization in patients with symptomatic ischemic heart failure (N. Engl. J. Med. 2011;364:1607-16). This study, also supported by NHLBI, was carried out in 26 countries throughout the world. In the 1,212 patients randomized to standard medical therapy alone, compared with medical therapy plus CABG, there was no significant benefit observed in the CABG patients in all-cause mortality, but there was a 19% decrease in cardiovascular mortality (P = .05) over a 3-year mean follow-up, and a 26% decrease in all-cause mortality and cardiovascular hospitalization (P less than .001). When patients who received CABG either by random assignment or because they were crossed over to surgery (620) were compared with those patients who remained on medical therapy (592), the effects of surgery were even more impressive, with a 30% decrease in all-cause mortality (P less than .001). The patients included in STICH were severely symptomatic, almost all with significant angina and 37% in NYHA HF class III/IV with a mean ejection fraction of 27%. Surgery carried an early up-front mortality risk of approximately 4%, which took about 2 years to overcome.

One interesting additional aspect of STICH was the viability study carried out in a subset of 601 patients using either dobutamine echocardiograms or SPECT stress testing. Although patients who demonstrated viability had a better outcome, viability did not define those patients who would benefit by CABG (N. Engl. J. Med. 2011;364:1617-25).

The “backstory” of the STICH trial was the failure of the U.S. cardiothoracic surgery centers to participate in it in a significant way. A total of 26 countries were required to achieve the 2,136 patients enrolled in the total STICH trial, and only 307 patients (14%) were American. The failure of the academic and large clinical centers to grasp the importance of this trial, and their reluctance to participate, was unfortunate.

The results of STICH indicate that the addition of CABG to patients already receiving optimal medical therapy provides a significant mortality and morbidity benefit. Unfortunately, viability studies do not provide helpful information in regard to the optimal selection of patients for CABG in ischemic heart failure. That decision appears to depend upon the availability of acceptable target vessels. But the data do support CABG, performed with an acceptable risk in experienced hands, as providing long-term benefits for heart failure patients.

Revascularization provides an additional mode of therapy for the treatment of patients with symptomatic ischemic heart failure, which could become a potential therapeutic target for percutaneous intervention in patients with the appropriate anatomy.

Coronary revascularization using bypass grafting with arterial or venous conduits has been with us since 1968 when Dr. Rene Favaloro performed the first saphenous venous graft for the treatment of angina pectoris (J. Thorac. Cardiovasc. Surg. 1969;58:178-85). Although it is clear that coronary artery bypass grafting (CABG) has been effective in decreasing symptomatic angina, with few exceptions there has been little to support its benefit in prolonging life. One of those exceptions was identified in a subgroup of the initial Coronary Artery Surgery Study carried out in the 1980s and sponsored by the National Heart, Lung, and Blood Institute (N. Engl. J. Med. 1985;312:1665-71). Of the 780 patients with chronic stable angina randomized to medicine only or CABG, there was a significant decrease in both angina and mortality in a subgroup of 160 patients with ejection fractions below 50%, primarily in patients with triple-vessel disease.

Since that report in 1985, there have been no clinical mortality trials examining the clinical benefit of CABG surgery in patients with ischemic heart failure. A randomized trial to evaluate the benefit of surgical ventricular reconstruction plus CABG, compared with CABG alone, failed to observe any benefit (N. Engl. J. Med. 2009:360;1705-17).

The suggestion that CABG could improve ventricular function is based on the observations by Dr. Shahbudin Rahimtoola in the 1980s in studies showing improved function in patients before and after CABG (Am. Heart J. 1989;117:211-21). He proposed the concept that areas of “hibernating myocardium” exist in the ischemic ventricle that can be revived by restoring its blood supply by CABG. But to a large degree, patients with ischemic heart failure have not been a prime target for CABG, and attempts to show clinical benefit in symptomatic improvement in heart failure has not been explored.

The recent report of the Surgical Treatment for Ischemic Heart Failure (STICH) trial has provided important information supporting the mortality and morbidity benefit of revascularization in patients with symptomatic ischemic heart failure (N. Engl. J. Med. 2011;364:1607-16). This study, also supported by NHLBI, was carried out in 26 countries throughout the world. In the 1,212 patients randomized to standard medical therapy alone, compared with medical therapy plus CABG, there was no significant benefit observed in the CABG patients in all-cause mortality, but there was a 19% decrease in cardiovascular mortality (P = .05) over a 3-year mean follow-up, and a 26% decrease in all-cause mortality and cardiovascular hospitalization (P less than .001). When patients who received CABG either by random assignment or because they were crossed over to surgery (620) were compared with those patients who remained on medical therapy (592), the effects of surgery were even more impressive, with a 30% decrease in all-cause mortality (P less than .001). The patients included in STICH were severely symptomatic, almost all with significant angina and 37% in NYHA HF class III/IV with a mean ejection fraction of 27%. Surgery carried an early up-front mortality risk of approximately 4%, which took about 2 years to overcome.

One interesting additional aspect of STICH was the viability study carried out in a subset of 601 patients using either dobutamine echocardiograms or SPECT stress testing. Although patients who demonstrated viability had a better outcome, viability did not define those patients who would benefit by CABG (N. Engl. J. Med. 2011;364:1617-25).

The “backstory” of the STICH trial was the failure of the U.S. cardiothoracic surgery centers to participate in it in a significant way. A total of 26 countries were required to achieve the 2,136 patients enrolled in the total STICH trial, and only 307 patients (14%) were American. The failure of the academic and large clinical centers to grasp the importance of this trial, and their reluctance to participate, was unfortunate.

The results of STICH indicate that the addition of CABG to patients already receiving optimal medical therapy provides a significant mortality and morbidity benefit. Unfortunately, viability studies do not provide helpful information in regard to the optimal selection of patients for CABG in ischemic heart failure. That decision appears to depend upon the availability of acceptable target vessels. But the data do support CABG, performed with an acceptable risk in experienced hands, as providing long-term benefits for heart failure patients.

Revascularization provides an additional mode of therapy for the treatment of patients with symptomatic ischemic heart failure, which could become a potential therapeutic target for percutaneous intervention in patients with the appropriate anatomy.

Thirty years ago, the Graduate Medical Education National Advisory Committee predicted a surplus of 145,000 physicians, including cardiologists, by the year 2000, and recommended a limitation of the number of entering positions in U.S. medical schools and the number of international graduates coming to the United States.

Although there was no restriction placed on international graduates coming to the United States, the number of positions available for students to enter U.S. medical schools has remained static until the last 2 years. This obstruction to medical school entry led many students to seek education at offshore medical schools (OMS), particularly in the Caribbean.

The flawed predictions of a surplus of doctors were made in anticipation of an expanded role of health maintenance organizations as gatekeepers for access to both family and specialty doctors. GMENAC also failed to foresee the expansion of the elderly population as a result of the baby boomer generation and the increased availability of new diagnostic and therapeutic technologies.

It is now estimated that by 2020 or 2025 there will be a shortage of almost 200,000 doctors in the United States (J. Gen. Intern. Med. 2007;22:264–8). U.S. medical schools are now projected to graduate 16,000 doctors annually, and that number is expected to increase by 30% in 2015, unless the proposed restrictions to education budgets by Congress come into place. However, this increase will continue to fall short of national requirements if physician retirement is factored into the estimates.

I recently had an opportunity to visit one of the Caribbean medical schools and to observe the students in the classroom. I also learned a great deal about the role that the OMS play in mitigating the doctor shortage in the United States. The students in these schools are clearly different from those who attend American medical schools. They are distinguished, not exclusively by their MCAT scores, as though that really matters, but also by being very motivated to become doctors. Many had been out of undergraduate programs for sometime – some as long 15 years – and had tested other careers and come to the realization that medicine is what they really wanted.

Most of these students will spend 2 years in the Caribbean and then move to clinical training in hospitals throughout the United States, ultimately entering residency programs and practice in mainland America.

One of the first hurdles that the OMS students will face is passing the United States Medical Licensing Examination taken by both U.S. and International Medical Graduates (IMGs). Measured against U.S. medical school graduates, who have a first-time passing rate of about 95%, they unfortunately fall short: The rate for non-U.S. IMGs is 73%, and that for American IMGs is lower still, at 60% (Health Aff. 2009;28:1226–33).

Upon the completion of their training, although they may go into subspecialties as do U.S. students, more of the Caribbean students enter family practice, a fact that has not been lost on health planners.

There have been some recent attempts to limit the number of training slots available for OMS students in New York City hospitals because of the presumed lack of total residency positions.

However, the state legislators, aware of current needs, have been reluctant to erect any barriers for physicians interested in family practice.

Currently there are 40 OMS in the Caribbean basin including Mexico, 24 of which were started in the last 10 years, which graduate more than 4,000 students annually in three classes, which vary in size between 60 and 600 students. Tuition is similar to that of U.S. schools and ranges from $47,500 to $186,085 for the 4 years. U.S. medical schools must be accredited by the Liaison Committee on Medical Education, but there is no accreditation process for OMS.

The LCME is now partnering with the Caribbean Accreditation Authority for Education in Medicine and Other Health Professions to establish similar accreditation processes. Federally supported scholarships are available to U.S. citizens in the OMS just as they are for students enrolled in U.S. schools. As a result of the high tuition and relatively low overhead, some of these schools have been targets for venture capitalists.

Of the 800,000 actively practicing doctors in the United States, 23.7% are IMGs, a percentage that is sure to increase. Approximately 60% of the IMGs are from the offshore medical schools.

It is clear that the United States has become increasingly dependent on OMS to meet our doctor supply. It is also clear that a vigorous attempt to improve the certification process for OMS would go a long way to ensure the quality of our future doctors.

Thirty years ago, the Graduate Medical Education National Advisory Committee predicted a surplus of 145,000 physicians, including cardiologists, by the year 2000, and recommended a limitation of the number of entering positions in U.S. medical schools and the number of international graduates coming to the United States.

Although there was no restriction placed on international graduates coming to the United States, the number of positions available for students to enter U.S. medical schools has remained static until the last 2 years. This obstruction to medical school entry led many students to seek education at offshore medical schools (OMS), particularly in the Caribbean.

The flawed predictions of a surplus of doctors were made in anticipation of an expanded role of health maintenance organizations as gatekeepers for access to both family and specialty doctors. GMENAC also failed to foresee the expansion of the elderly population as a result of the baby boomer generation and the increased availability of new diagnostic and therapeutic technologies.

It is now estimated that by 2020 or 2025 there will be a shortage of almost 200,000 doctors in the United States (J. Gen. Intern. Med. 2007;22:264–8). U.S. medical schools are now projected to graduate 16,000 doctors annually, and that number is expected to increase by 30% in 2015, unless the proposed restrictions to education budgets by Congress come into place. However, this increase will continue to fall short of national requirements if physician retirement is factored into the estimates.

I recently had an opportunity to visit one of the Caribbean medical schools and to observe the students in the classroom. I also learned a great deal about the role that the OMS play in mitigating the doctor shortage in the United States. The students in these schools are clearly different from those who attend American medical schools. They are distinguished, not exclusively by their MCAT scores, as though that really matters, but also by being very motivated to become doctors. Many had been out of undergraduate programs for sometime – some as long 15 years – and had tested other careers and come to the realization that medicine is what they really wanted.

Most of these students will spend 2 years in the Caribbean and then move to clinical training in hospitals throughout the United States, ultimately entering residency programs and practice in mainland America.

One of the first hurdles that the OMS students will face is passing the United States Medical Licensing Examination taken by both U.S. and International Medical Graduates (IMGs). Measured against U.S. medical school graduates, who have a first-time passing rate of about 95%, they unfortunately fall short: The rate for non-U.S. IMGs is 73%, and that for American IMGs is lower still, at 60% (Health Aff. 2009;28:1226–33).

Upon the completion of their training, although they may go into subspecialties as do U.S. students, more of the Caribbean students enter family practice, a fact that has not been lost on health planners.

There have been some recent attempts to limit the number of training slots available for OMS students in New York City hospitals because of the presumed lack of total residency positions.

However, the state legislators, aware of current needs, have been reluctant to erect any barriers for physicians interested in family practice.

Currently there are 40 OMS in the Caribbean basin including Mexico, 24 of which were started in the last 10 years, which graduate more than 4,000 students annually in three classes, which vary in size between 60 and 600 students. Tuition is similar to that of U.S. schools and ranges from $47,500 to $186,085 for the 4 years. U.S. medical schools must be accredited by the Liaison Committee on Medical Education, but there is no accreditation process for OMS.

The LCME is now partnering with the Caribbean Accreditation Authority for Education in Medicine and Other Health Professions to establish similar accreditation processes. Federally supported scholarships are available to U.S. citizens in the OMS just as they are for students enrolled in U.S. schools. As a result of the high tuition and relatively low overhead, some of these schools have been targets for venture capitalists.

Of the 800,000 actively practicing doctors in the United States, 23.7% are IMGs, a percentage that is sure to increase. Approximately 60% of the IMGs are from the offshore medical schools.

It is clear that the United States has become increasingly dependent on OMS to meet our doctor supply. It is also clear that a vigorous attempt to improve the certification process for OMS would go a long way to ensure the quality of our future doctors.

Thirty years ago, the Graduate Medical Education National Advisory Committee predicted a surplus of 145,000 physicians, including cardiologists, by the year 2000, and recommended a limitation of the number of entering positions in U.S. medical schools and the number of international graduates coming to the United States.

Although there was no restriction placed on international graduates coming to the United States, the number of positions available for students to enter U.S. medical schools has remained static until the last 2 years. This obstruction to medical school entry led many students to seek education at offshore medical schools (OMS), particularly in the Caribbean.

The flawed predictions of a surplus of doctors were made in anticipation of an expanded role of health maintenance organizations as gatekeepers for access to both family and specialty doctors. GMENAC also failed to foresee the expansion of the elderly population as a result of the baby boomer generation and the increased availability of new diagnostic and therapeutic technologies.

It is now estimated that by 2020 or 2025 there will be a shortage of almost 200,000 doctors in the United States (J. Gen. Intern. Med. 2007;22:264–8). U.S. medical schools are now projected to graduate 16,000 doctors annually, and that number is expected to increase by 30% in 2015, unless the proposed restrictions to education budgets by Congress come into place. However, this increase will continue to fall short of national requirements if physician retirement is factored into the estimates.

I recently had an opportunity to visit one of the Caribbean medical schools and to observe the students in the classroom. I also learned a great deal about the role that the OMS play in mitigating the doctor shortage in the United States. The students in these schools are clearly different from those who attend American medical schools. They are distinguished, not exclusively by their MCAT scores, as though that really matters, but also by being very motivated to become doctors. Many had been out of undergraduate programs for sometime – some as long 15 years – and had tested other careers and come to the realization that medicine is what they really wanted.

Most of these students will spend 2 years in the Caribbean and then move to clinical training in hospitals throughout the United States, ultimately entering residency programs and practice in mainland America.

One of the first hurdles that the OMS students will face is passing the United States Medical Licensing Examination taken by both U.S. and International Medical Graduates (IMGs). Measured against U.S. medical school graduates, who have a first-time passing rate of about 95%, they unfortunately fall short: The rate for non-U.S. IMGs is 73%, and that for American IMGs is lower still, at 60% (Health Aff. 2009;28:1226–33).

Upon the completion of their training, although they may go into subspecialties as do U.S. students, more of the Caribbean students enter family practice, a fact that has not been lost on health planners.

There have been some recent attempts to limit the number of training slots available for OMS students in New York City hospitals because of the presumed lack of total residency positions.

However, the state legislators, aware of current needs, have been reluctant to erect any barriers for physicians interested in family practice.

Currently there are 40 OMS in the Caribbean basin including Mexico, 24 of which were started in the last 10 years, which graduate more than 4,000 students annually in three classes, which vary in size between 60 and 600 students. Tuition is similar to that of U.S. schools and ranges from $47,500 to $186,085 for the 4 years. U.S. medical schools must be accredited by the Liaison Committee on Medical Education, but there is no accreditation process for OMS.

The LCME is now partnering with the Caribbean Accreditation Authority for Education in Medicine and Other Health Professions to establish similar accreditation processes. Federally supported scholarships are available to U.S. citizens in the OMS just as they are for students enrolled in U.S. schools. As a result of the high tuition and relatively low overhead, some of these schools have been targets for venture capitalists.

Of the 800,000 actively practicing doctors in the United States, 23.7% are IMGs, a percentage that is sure to increase. Approximately 60% of the IMGs are from the offshore medical schools.

It is clear that the United States has become increasingly dependent on OMS to meet our doctor supply. It is also clear that a vigorous attempt to improve the certification process for OMS would go a long way to ensure the quality of our future doctors.

A recent analysis of the ICD Registry from the National Cardiovascular Data Registry raises significant concerns about the effectiveness of the treatment guidelines for implantable cardioverter defibrillators for the primary prevention of sudden cardiac arrhythmic death.

That study indicates that, although the guidelines as proposed by the sponsoring societies were adhered to in most implantations, a disappointing one-quarter of the implantations were outside of the guidelines. Of the over 111,707 ICDs implanted between 2006 and 2009, 25,145 (22.5%) were implanted in patients who were outside of the recommended guidelines. Certainly one can make a case for the fact that these are only guidelines, and doctor should have the prerogative to make clinical decisions, but there have been few guidelines that have been as carefully explored as those for ICD implantation. They emphasize not only the benefit of the devices implanted within the guidelines, but the hazards of the implantation outside of the guidelines (JAMA 2011;305:43-9).

Four guideline deviations were identified and included implantation carried out within 40 days of an acute MI, in 37%; within 3 months of coronary artery bypass surgery, in 3%; in patients with New York Heart Association class IV symptoms, in 12%; and in newly diagnosed heart failure, in 62%. There are adequate randomized clinical trials that clearly show the lack of benefit or increased risks of implantation in these four classes of patients.

Both the cardiology community and the device manufacturers have emphasized the importance of ICD therapy in as many individuals who fit the criteria for implantation as possible. Despite this effort, the implantation of ICDs on the potential candidates with systolic heart failure has significantly lagged. These results may have a further cooling effect on the rate of future implantation.

There are adequate randomized clinical trials that clearly demonstrate the lack of benefit or increased risks of implantation in these four classes of heart failure patients. The delay in implantation in new heart failure patients has been dictated by the observations that many individuals improve cardiac function after an acute event. In addition, a number of studies have shown that implantation at time of surgery is without merit and with some risk, and we have learned that the mode of death in NYHA class IV patients is dominated by progressive heart failure and not primary arrhythmias.

The use of ICDs within 40 days of an acute MI is of particular importance. Several studies have raised concern about the increase in heart failure mortality in patients who have experienced both appropriate and inappropriate ICD discharge for arrhythmias. It is unclear whether the increased heart failure precedes or is a result of ICD discharge. Similar observations were made in patients in whom an ICD was implanted early after an acute MI for the primary prevention of arrhythmic deaths. A recent study of the Defibrillation in Acute Myocardial Infarction Trial (DINAMIT) re-examines the observation that that heart failure mortality increased in patients who received an ICD shock (Circulation 2010;122:2645-52). DINAMIT enrolled patients 6–40 days after an acute MI in patients with left ventricular ejection fraction of less than 35%. Although ICD therapy decreased arrhythmic deaths, there was an increase in heart failure mortality in those patients who had an ICD shock, which resulted in a net increased mortality.

Both the American College of Cardiology and the Heart Rhythm Society have expressed concern about the recent report and plan to further emphasize ICD guidelines. The HRS is cooperating with the Department of Justice in an investigation of the inappropriate Medicare payments of ICDs “to lend expertise concerning the proper guidelines for clinical decision making,” according to a statement. Should the Justice Department become involved in the appropriate use of medical guidelines, an entirely new disturbing dimension would be introduced in regard to guideline application. In the meantime, both cardiologists and noncardiologists should rethink their decisions in regard to the use of ICDs. They clearly represent an important medical advance that has saved the lives of many of our patients, but their use does have significant risks which must be balanced against their benefit.

A recent analysis of the ICD Registry from the National Cardiovascular Data Registry raises significant concerns about the effectiveness of the treatment guidelines for implantable cardioverter defibrillators for the primary prevention of sudden cardiac arrhythmic death.

That study indicates that, although the guidelines as proposed by the sponsoring societies were adhered to in most implantations, a disappointing one-quarter of the implantations were outside of the guidelines. Of the over 111,707 ICDs implanted between 2006 and 2009, 25,145 (22.5%) were implanted in patients who were outside of the recommended guidelines. Certainly one can make a case for the fact that these are only guidelines, and doctor should have the prerogative to make clinical decisions, but there have been few guidelines that have been as carefully explored as those for ICD implantation. They emphasize not only the benefit of the devices implanted within the guidelines, but the hazards of the implantation outside of the guidelines (JAMA 2011;305:43-9).

Four guideline deviations were identified and included implantation carried out within 40 days of an acute MI, in 37%; within 3 months of coronary artery bypass surgery, in 3%; in patients with New York Heart Association class IV symptoms, in 12%; and in newly diagnosed heart failure, in 62%. There are adequate randomized clinical trials that clearly show the lack of benefit or increased risks of implantation in these four classes of patients.

Both the cardiology community and the device manufacturers have emphasized the importance of ICD therapy in as many individuals who fit the criteria for implantation as possible. Despite this effort, the implantation of ICDs on the potential candidates with systolic heart failure has significantly lagged. These results may have a further cooling effect on the rate of future implantation.

There are adequate randomized clinical trials that clearly demonstrate the lack of benefit or increased risks of implantation in these four classes of heart failure patients. The delay in implantation in new heart failure patients has been dictated by the observations that many individuals improve cardiac function after an acute event. In addition, a number of studies have shown that implantation at time of surgery is without merit and with some risk, and we have learned that the mode of death in NYHA class IV patients is dominated by progressive heart failure and not primary arrhythmias.

The use of ICDs within 40 days of an acute MI is of particular importance. Several studies have raised concern about the increase in heart failure mortality in patients who have experienced both appropriate and inappropriate ICD discharge for arrhythmias. It is unclear whether the increased heart failure precedes or is a result of ICD discharge. Similar observations were made in patients in whom an ICD was implanted early after an acute MI for the primary prevention of arrhythmic deaths. A recent study of the Defibrillation in Acute Myocardial Infarction Trial (DINAMIT) re-examines the observation that that heart failure mortality increased in patients who received an ICD shock (Circulation 2010;122:2645-52). DINAMIT enrolled patients 6–40 days after an acute MI in patients with left ventricular ejection fraction of less than 35%. Although ICD therapy decreased arrhythmic deaths, there was an increase in heart failure mortality in those patients who had an ICD shock, which resulted in a net increased mortality.

Both the American College of Cardiology and the Heart Rhythm Society have expressed concern about the recent report and plan to further emphasize ICD guidelines. The HRS is cooperating with the Department of Justice in an investigation of the inappropriate Medicare payments of ICDs “to lend expertise concerning the proper guidelines for clinical decision making,” according to a statement. Should the Justice Department become involved in the appropriate use of medical guidelines, an entirely new disturbing dimension would be introduced in regard to guideline application. In the meantime, both cardiologists and noncardiologists should rethink their decisions in regard to the use of ICDs. They clearly represent an important medical advance that has saved the lives of many of our patients, but their use does have significant risks which must be balanced against their benefit.

A recent analysis of the ICD Registry from the National Cardiovascular Data Registry raises significant concerns about the effectiveness of the treatment guidelines for implantable cardioverter defibrillators for the primary prevention of sudden cardiac arrhythmic death.

That study indicates that, although the guidelines as proposed by the sponsoring societies were adhered to in most implantations, a disappointing one-quarter of the implantations were outside of the guidelines. Of the over 111,707 ICDs implanted between 2006 and 2009, 25,145 (22.5%) were implanted in patients who were outside of the recommended guidelines. Certainly one can make a case for the fact that these are only guidelines, and doctor should have the prerogative to make clinical decisions, but there have been few guidelines that have been as carefully explored as those for ICD implantation. They emphasize not only the benefit of the devices implanted within the guidelines, but the hazards of the implantation outside of the guidelines (JAMA 2011;305:43-9).

Four guideline deviations were identified and included implantation carried out within 40 days of an acute MI, in 37%; within 3 months of coronary artery bypass surgery, in 3%; in patients with New York Heart Association class IV symptoms, in 12%; and in newly diagnosed heart failure, in 62%. There are adequate randomized clinical trials that clearly show the lack of benefit or increased risks of implantation in these four classes of patients.

Both the cardiology community and the device manufacturers have emphasized the importance of ICD therapy in as many individuals who fit the criteria for implantation as possible. Despite this effort, the implantation of ICDs on the potential candidates with systolic heart failure has significantly lagged. These results may have a further cooling effect on the rate of future implantation.

There are adequate randomized clinical trials that clearly demonstrate the lack of benefit or increased risks of implantation in these four classes of heart failure patients. The delay in implantation in new heart failure patients has been dictated by the observations that many individuals improve cardiac function after an acute event. In addition, a number of studies have shown that implantation at time of surgery is without merit and with some risk, and we have learned that the mode of death in NYHA class IV patients is dominated by progressive heart failure and not primary arrhythmias.

The use of ICDs within 40 days of an acute MI is of particular importance. Several studies have raised concern about the increase in heart failure mortality in patients who have experienced both appropriate and inappropriate ICD discharge for arrhythmias. It is unclear whether the increased heart failure precedes or is a result of ICD discharge. Similar observations were made in patients in whom an ICD was implanted early after an acute MI for the primary prevention of arrhythmic deaths. A recent study of the Defibrillation in Acute Myocardial Infarction Trial (DINAMIT) re-examines the observation that that heart failure mortality increased in patients who received an ICD shock (Circulation 2010;122:2645-52). DINAMIT enrolled patients 6–40 days after an acute MI in patients with left ventricular ejection fraction of less than 35%. Although ICD therapy decreased arrhythmic deaths, there was an increase in heart failure mortality in those patients who had an ICD shock, which resulted in a net increased mortality.

Both the American College of Cardiology and the Heart Rhythm Society have expressed concern about the recent report and plan to further emphasize ICD guidelines. The HRS is cooperating with the Department of Justice in an investigation of the inappropriate Medicare payments of ICDs “to lend expertise concerning the proper guidelines for clinical decision making,” according to a statement. Should the Justice Department become involved in the appropriate use of medical guidelines, an entirely new disturbing dimension would be introduced in regard to guideline application. In the meantime, both cardiologists and noncardiologists should rethink their decisions in regard to the use of ICDs. They clearly represent an important medical advance that has saved the lives of many of our patients, but their use does have significant risks which must be balanced against their benefit.